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JPH11513273A - Device for mounting a heart valve holder on an artificial heart valve - Google Patents

Device for mounting a heart valve holder on an artificial heart valve

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Publication number
JPH11513273A
JPH11513273A JP9512034A JP51203497A JPH11513273A JP H11513273 A JPH11513273 A JP H11513273A JP 9512034 A JP9512034 A JP 9512034A JP 51203497 A JP51203497 A JP 51203497A JP H11513273 A JPH11513273 A JP H11513273A
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JP
Japan
Prior art keywords
suture
heart valve
holder
holder body
valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP9512034A
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Japanese (ja)
Inventor
ディー． クルーガー，カート
バネイ，ガイ，ピー．
Original Assignee
セント ジュード メディカル，インコーポレイテッド
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Application filed by セント ジュード メディカル，インコーポレイテッド filed Critical セント ジュード メディカル，インコーポレイテッド
Publication of JPH11513273A publication Critical patent/JPH11513273A/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30461—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

(57)【要約】 移植手術の間人工心臓弁（１０）に係合するための装置（２０）は、この装置（２０）を人工心臓弁（１０）に取り付けるための機構を具備する。人工心臓弁（１０）は環状弁本体（１４）を具備し、この環状弁本体はその内側に実質的に環状の開口を有する環帯を有する。この環帯には少なくとも１つの可動閉塞器（１８）が坦持され、これは開放位置と閉塞位置との間を移動可能である。この閉塞器は弁本体（１４）に連結する縫合糸（１２）上に坦持される。取り付け機構は、縫合糸（１２）に連結し、それにより装置（２０）を人工心臓弁（１０）に固定する部材を具備する。この取り付け機構は、人工心臓弁（１０）を解放するように駆動させることができる。 (57) Abstract: A device (20) for engaging a prosthetic heart valve (10) during a transplant operation includes a mechanism for attaching the device (20) to the prosthetic heart valve (10). The prosthetic heart valve (10) comprises an annular valve body (14) having an annulus with a substantially annular opening therein. The annulus carries at least one movable obturator (18), which is movable between an open position and a closed position. The occluder is carried on a suture (12) that connects to the valve body (14). The attachment mechanism comprises a member that connects to the suture (12), thereby securing the device (20) to the prosthetic heart valve (10). This attachment mechanism can be driven to release the prosthetic heart valve (10).

Description

【発明の詳細な説明】 発明の名称 人工心臓弁に心臓弁ホルダを装着するための装置 本発明は人工心臓弁を移植手術するための装置に関する。より具体的には、本 発明は、人工心臓への心臓弁ホルダの装着に関する。 発明の背景 移植手術の間、人工心臓弁を保持するホルダ類は公知である。これらは、手術 の間の弁の位置決め、保持、支持及び差し出しのために用いられる。１９７４年 ８月１３日に発行されたアンダーソン（Anderson）らの「心臓弁を保持するため のコレット」と題する米国特許３，８２８，７８７号には、延長された柄の末端 に坦持された心臓弁ホルダが示されている。１９９０年６月１２日に発行された フィリップス（Phillips）の「人工弁、並びに針及び縫合糸ホルダ、並びにそれ らの使用方法」と題する米国特許４，９３２，９６５号には、移植手術の間弁が 一対の延長された脚の遠位端に対して保持される別の心臓弁ホルダが示されてい る。 典型的には、心臓弁置換術は、胸肋切開又は開胸を行い、患者の心臓にアクセ スするために患者の胸腔を大きく広げなければならない複雑な手順である。これ により、外科医はなにものにも邪魔されることなく心臓を直接扱うことができる 。しかしながら、この手順は、上半身に受けた外傷の回復に長期間を要する。 近年、患者の肋骨の間の小切開部に配置されたトロカールを介し て開心術を行う手順が開発されている。これは、「心臓内処置のための装置及び 方法」と題する国際公開ＷＯ９５／１５７１５号、１９９５年７月１８日に発行 されたピータース（Peters）の「心臓麻痺性停止を腔内的に誘発する方法及びそ こで用いるためのカテーテル」と題する米国特許５，４３３，７００号、及び１ ９９５年６月２０日に発行されたエバード（Evard）らの、「胸腔鏡検査用装置 及び心臓を停止させる方法」と題する米国特許５，４２５，７０５号、並びに「 胸腔鏡下心臓バイパス術を行う方法」と題する国際公開ＷＯ９４／１８８８１号 に説明されている。 この手順においては、心臓に対する手術に、延長された道具がトロカールを介 して用いられる。公開ＷＯ９５／１５７１５号に論じられるように、この手順は 心臓弁置換の過程で用いることが可能である。トロカールを通して人工心臓弁を 挿入する際には、弁内の閉塞器（occluders）を保護するために細心の注意が払 われ、ひとたび挿入されると、その人工心臓弁の適所での縫合を簡単にするため 、装着に先立って弁の向きを変えることが望ましいものとなる。 トロカールは肋骨の広がりを最少に留め、伝統的な開心術に伴う大きな胸部外 傷は伴わない。この手順の利点の１つは、回復期間を大きく短縮させることがで きることである。不幸にして、移植手術に用いられる機械的心臓弁及び関連組立 体は肋骨間の肋間腔に対して大きく、そこを通過するように適合させることは困 難である。さらに、心臓弁ホルダは、人工心臓弁に確実に取り付けられながらも 、 ひとたび弁が心臓組織環帯に取り付けられてしまったならば容易に取り除かれな ければならない。 発明の概要 移植手術の間人工心臓弁に係合するための装置は、その装置を人工心臓弁に取 り付ける機構を有する。人工心臓弁は環状弁本体を有し、この環状弁本体はその 内部に実質的に環状の開口部を有する環帯を有する。この環帯には少なくとも１ つの可動性閉塞器が備えられ、これは開放位置と閉塞位置との間を移動すること が可能である。この閉塞器は、人工心臓弁の軸と平行の方向に延びる部分を有す る少なくとも１本の延長された支材に坦持される。取り付け機構は、支材に連結 し、それによりその装置を支材の部分で人工心臓弁に固定させる部材を含む。こ の部材は支材から選択的に取り外し、それにより、その装置を支材から外すこと が可能である。一態様においては、延長された柄（ハンドル）がこの装置に連結 し、人工心臓の環帯によって形成される平面とほぼ平行な平面内を、この装置か ら遠ざかるように延びる。 図面の簡単な説明 図１は、本発明によるホルダと共に用いるための、従来技術の心臓弁の俯瞰図 である。 図２Ａは、図２Ｂに示される心臓弁ホルダ及び心臓弁の２Ａ−２Ａ線に沿って 採られた側断面図であり、人工心臓弁と係合された本発明の一態様を示している 。 図２Ｂは、図２Ａの心臓弁ホルダの頂部平面図である。 図３Ａは、図３Ｂに示される心臓弁ホルダの３Ａ−３Ａ線に沿って採られた断 面図であり、人工心臓弁と係合された別の態様を示している。 図３Ｂは、図３Ａの心臓弁ホルダ及び人工心臓弁の頂部平面図である。 図４Ａは、図４Ｂに示されるホルダの４Ｂ−４Ｂ線に沿って採られた断面図で あり、人工心臓弁と係合された別の態様を示している。 図４Ｂは、図４Ａのホルダの頂部平面図である。 好ましい実施態様の詳細な説明 本発明は、人工心臓弁ホルダの人工心臓弁への取り付けに関する。このホルダ は移植手術の間の人工心臓弁の位置決めに用いられる。一態様において、この移 植手術は、小さなトロカール又は類似の装置によって行われる場合のような、侵 襲性が最少の外科手術によるものである。ホルダ及び弁は、トロカールを介して 挿入されている間、弁環帯の軸に垂直に延びる柄の遠位端に坦持される。この発 明の説明のために、まずホルダ及び取り付け機構を一般的に説明する。 このホルダ及び取り付け機構はあらゆる適当な人工心臓弁と共に用いることが 可能であり、この適当な人工心臓弁にはミネソタ州ミネアポリスのメドトロニッ ク社（Medtronic,Inc.）、カリフォルニア州アービングのシレイ社（Shiley,Inc .）、及びミネソタ州グローブハイトのオムニサイエンス・メディカル社（Omnis cience Medical Inc.）から入手可能な人工心臓弁が含まれる。一般には、ここに示され た人工心臓弁は概略的な形態であり、本発明の範囲は、ホルダ及び取り付け機構 を異なる人工心臓弁に適合させるのに必要な変形をも含むことが意図されている 。 図１は人工心臓弁１０の俯瞰図である。人工心臓弁１０はミネソタ州ミネアポ リスのメドトロニック社から入手可能であり、主支材１２を含む型の人工心臓弁 を説明するものである。主支材１２は人工心臓弁本体１４に連結する。心臓弁本 体１４は、そこを通過する血流のための、実質的に円形の環帯を形成している。 縫合カフ１６が弁本体１４に取り付けられており、患者の心臓への弁１０の取り 付けに用いられる。閉塞器１８はオリフィス体１４によって形成される環帯内に 位置し、主支材１２で案内されている。閉塞器１８は、図１に示される開放位置 と閉塞位置との間で移動することができる。主支材１２は閉塞器１８に案内機構 を提供し、これは延長された部材で形成され、その一部は弁１０の軸に平行に延 びている。支材を配置する人工心臓弁の他の例は、例えば、米国特許３，８２８ ，７８７号、３，７８１，９６９号、及び４，５３２，６５９号に示されている 。 支材が心臓弁ホルダを人工心臓に取り付けるための有用な取り付け点であるこ とが発見されている。支材は、外形が低いデザインの心臓弁ホルダの人工心臓弁 への取り付けにおいて特に有用である。このような外形が低い（low profile） デザインは、国際公開ＷＯ ９５／１５７１５号に記述される侵襲性が最少の技術に使用するのに良く適合す る。 図２Ａは、図１の人工心臓弁１０と係合された、本発明の一態様に従う弁ホル ダ２０の側断面図である。人工弁１０は、図１においては見えなかった弁第２支 材２２を含む。図２Ｂはホルダ２０の頂部平面図であり、それを通して突き出し た主支材１２を示す。 ホルダ２０は、人工心臓弁本体１４の縁２６内に嵌合させるのに適するホルダ 本体２４を有する。ホルダ本体２４は、それを通して主支材１２を受ける支材開 口部２８を有する。閉塞器係合表面３０及び３２が人工心臓弁ホルダ本体２４か ら延び、図２Ａに実質的に示されるように閉塞体１８と係合する。表面３０及び ３２は閉塞器１８を閉塞位置に維持する。ロック（locking）バー３４は、主支 材１２とホルダ本体２４との間で、主支材１２を通して嵌合する。ロックバー３ ４は、ばね負荷されたロックバーカンチレバ３６を介してホルダ本体２４に連結 する。 ホルダ２０はホルダ本体２４と人工心臓弁本体１４の縁２６との間の接触面（ interface）で人工心臓弁１０と結合し、ロックバー３４と主支材１２との接触 面によって固定される。結合フランジ４０はホルダ本体２４上の表面２３の上部 に広がり、それを通して縫合糸４２を受ける。縫合糸４２は縫合糸孔４４及びロ ックバー３４を貫通して延び、ロックバー３４を図２Ｂに示されるロック位置に 固定する。 移植手術の間、外科医は、弁１０の平面とほぼ平行であり、かつ弁１０の軸に ほぼ垂直の方向に延びる延長された柄４８を用いて弁１０を操作する。外科医は 、縫合カフ１６を用いて弁１０を心臓組織環帯に縫合する。心臓組織環帯への弁 １０の取り付けに続いて、縫合糸４２を切断し、それによりカンチレバ３６がロ ックバー３４と主縫合糸１２との係合を解除させることにより、ホルダ２０を取 り除く。ロックバー３４と主縫合糸１２との係合の解除に続いて、ホルダ２０を 弁１０から持ち上げ、それにより閉塞器１８が主縫合糸１２を支点にして自由に 旋回できるようにする。移植手術の間、閉塞器１８は実質的に閉塞位置に保持さ れ、人工心臓弁本体１４及びホルダ２０によって保護される。 図３Ａは、人工心臓弁１０と係合されている、別の態様に従う心臓弁ホルダ６ ０の側断面図である。ホルダ６０はホルダ本体６２を有し、ホルダ本体６２はそ れを貫通する縫合糸孔６４を有する。縫合糸開口部６４は主縫合糸１２を受ける のに適合する。ホルダ本体６２は閉塞器１８との係合に適する閉塞器接触面６６ を有する。接触面６６は、閉塞器１８を、図３Ａに示される閉塞位置に維持する 。縫合糸開口部７０はホルダ本体６２を貫通して延び、縫合糸７２を受け入れる 。縫合糸７２はカフ１６を貫通して延び、その結果、縫合糸７２及び開口部６４ を貫通して延びる主縫合糸１２によって、ホルダ６０が人工心臓弁１０に取り付 けられる。 移植手術に続いて、縫合糸７２を切断することによりホルダ６０ を取り外す。その後、ホルダ６０を主縫合糸１２から持ち上げ、それにより閉塞 器１８を解放する。典型的には、柄（図３Ａ及び図３Ｂには示さず）がホルダ６ ０から弁オリフィス体１４の面と平行の方向（すなわち、側方）に延び、これが 移植手術の間弁１０を操作するのに用いられる。 図４Ａは、人工心臓弁１０と係合されている、別の態様に従う心臓弁ホルダ８ ０の断面図である。図４Ｂは、人工心臓弁１０と係合されているホルダ８０の頂 部平面図である。ホルダ８０は、本体部８２Ａ及び８２Ｂ並びにロック部８４Ａ 及び８４Ｂを有する。本体部８２Ａ及び８２Ｂはヒンジ８６で結合され、固定部 ８４Ａ及び８４Ｂは８８で示される鎖線に沿って分離されている。ホルダ８０が 図４Ｂに示される位置にある場合、固定部８４Ａ及び８４Ｂは主縫合糸１２の下 で線８８に沿って接触衝合する。ホルダ８０は、固定部８４Ａ及び８４Ｂによっ て形成される面９０を有し、これは閉塞器１８と係合する。面９２は本体部８２ Ａ及び８２Ｂによって形成され、これは閉塞器１８との係合に適合する。 図４Ｂに示される係合位置において、閉塞器１８は、図４Ａに示される閉塞位 置に保持される。固定部８４Ａ及び８４Ｂは縫合糸孔９６を貫通して延びる縫合 糸９４によって一緒に保持される。弁１０の移植手術に続いて、縫合糸９４を切 断することにより、本体部８２Ａ及び８２Ｂが一緒に動けるようになってヒンジ ８６の周りに旋回し、それにより部分８４Ａ及び８４Ｂが移動して離れ、心臓 弁１０がホルダ８０から解放されるように、ホルダ８０を取り外す。ヒンジ８６ は、本体部８２Ａ及び８２Ｂと一体に形成された可撓性材料を含むあらゆる適当 なヒンジ機構であり得る。典型的には、図４Ａ及び４Ｂには示されない延長され た柄が弁オリフィス体１４の面に平行な方向（すなわち、側方）に弁ホルダ８０ から離れて延び、これが移植手術の間の弁１０の操作を可能にする。 図４Ａ及び４Ｂに示されるホルダ８０の態様の変形は取外し用ヒンジ８６を有 するので、ホルダ８０は、一方の半分（half）部分８２Ａ及び８４Ａを含み、他 方が部分８２Ｂ及び８４Ｂを含む２つの半分に分離可能である。この態様におい ては、縫合糸のような第２の取り付け機構が部分８２Ａと８２Ｂとの間に延びて いる。 本発明は、当該技術分野における熟練者に明らかなあらゆる変形又は態様にま で広がることは理解されるべきである。ここに説明された概念は、大動脈及び僧 帽弁の両者の移植手術のためのあらゆる適当な弁形状に適用可能である。例えば 、ここでなされている説明においても、僧帽弁と大動脈の構成が入れ替えられて いる（図３Ａ及び３Ｂを図１、２Ａ、２Ｂ、４Ａ及び４Ｂと比較すれば分かるよ うに）。さらに、縫合糸は、それが本発明の範囲内の係合機構及び技術を利用し 得る限りにおいて、人工心臓弁の他の適当な位置に配置されることが可能である 。移植手術の間閉塞器を固定するため、保持機構をどの実施態様にも含めること ができる。移植手術の間人工心臓弁を操作するため、延長された柄をここに説明 されるホルダ に取り付けることができる。 本発明を好ましい態様を引用して説明したが、当該技術分野における熟練者は 、本発明の精神及び範囲から逸脱することなく形態及び詳細に変更をなし得るこ とを認めるであろう。DETAILED DESCRIPTION OF THE INVENTION   Title of invention         Device for mounting a heart valve holder on an artificial heart valve   The present invention relates to a device for implanting a prosthetic heart valve. More specifically, the book The invention relates to mounting a heart valve holder on an artificial heart.   Background of the Invention   Holders for holding a prosthetic heart valve during an implantation procedure are known. These are surgery Used for positioning, holding, supporting and extending the valve during 1974 Anderson et al., Published August 13, "To hold heart valves. U.S. Pat. No. 3,828,787 entitled "Collet of the A heart valve holder is shown carried by the heart valve holder. Issued on June 12, 1990 Phillips "Prosthetic Valves and Needle and Suture Holders and the Same" U.S. Pat. No. 4,932,965, entitled "How to Use Them", discloses a valve during transplantation. Another heart valve holder held against the distal ends of a pair of extended legs is shown. You.   Typically, heart valve replacement involves performing a thoracotomy or thoracotomy to access the patient's heart. This is a complicated procedure that requires the patient's thoracic cavity to be greatly expanded in order to perform the procedure. this Allows surgeons to work directly with the heart without disturbing anything . However, this procedure takes a long time to recover from trauma to the upper body.   Recently, a trocar has been placed in the small incision between the patient's ribs. Procedures for performing open heart surgery have been developed. This includes "devices for intracardiac procedures and WO95 / 15715 entitled "Method", published July 18, 1995. Peters, "How to induce endocardial arrest in a cavity and its U.S. Pat. No. 5,433,700 entitled "Catheter for Use Here" and 1 Evard et al., Published June 20, 995, entitled "Thoracoscopy Equipment." And US Patent No. 5,425,705 entitled "How to Stop a Heart" WO94 / 18881 entitled "Method of performing thoracoscopic heart bypass surgery" Is described in   In this procedure, an extended tool is used to operate the heart via a trocar. Used as As discussed in published WO 95/15715, this procedure It can be used in the process of heart valve replacement. Prosthetic heart valve through trocar Extreme care must be taken during insertion to protect occluders within the valve. Once inserted, to facilitate suturing of the prosthetic heart valve in place It would be desirable to change the orientation of the valve prior to mounting.   The trocar minimizes the spread of the ribs and provides a large extra-thoracic area with traditional open heart surgery No scratches. One of the benefits of this procedure is that it can significantly reduce the recovery period. It is possible. Unfortunately, mechanical heart valves and associated assemblies used in transplant surgery The body is large for the intercostal space between the ribs and it is difficult to fit It is difficult. In addition, the heart valve holder is securely attached to the prosthetic heart valve, , Once the valve has been attached to the heart tissue annulus, it cannot be easily removed. I have to.   Summary of the Invention   A device for engaging a prosthetic heart valve during a transplant procedure may include attaching the device to the prosthetic heart valve. Has a fastening mechanism. The prosthetic heart valve has an annular valve body, which is It has an annulus having a substantially annular opening therein. At least one There are two movable occluders, which move between open and closed positions Is possible. The occluder has a portion extending in a direction parallel to the axis of the prosthetic heart valve Supported by at least one extended strut. The mounting mechanism is connected to the strut And includes a member that secures the device to the prosthetic heart valve at the strut. This Parts are selectively removed from the strut, thereby removing the device from the strut. Is possible. In one aspect, an extended handle (handle) is connected to the device. The device is placed in a plane approximately parallel to the plane formed by the annulus of the artificial heart. It extends away from it.   BRIEF DESCRIPTION OF THE FIGURES   FIG. 1 is an overhead view of a prior art heart valve for use with a holder according to the present invention. It is.   FIG. 2A shows the heart valve holder and the heart valve shown in FIG. 2B along line 2A-2A. 1 is a side cross-sectional view taken, showing one embodiment of the present invention engaged with a prosthetic heart valve. .   FIG. 2B is a top plan view of the heart valve holder of FIG. 2A.   FIG. 3A shows a cross-section taken along line 3A-3A of the heart valve holder shown in FIG. 3B. FIG. 5 is a front view, showing another embodiment engaged with a prosthetic heart valve.   FIG. 3B is a top plan view of the heart valve holder and the prosthetic heart valve of FIG. 3A.   FIG. 4A is a sectional view taken along line 4B-4B of the holder shown in FIG. 4B. And another embodiment engaged with a prosthetic heart valve.   FIG. 4B is a top plan view of the holder of FIG. 4A.   Detailed Description of the Preferred Embodiment   The present invention relates to the attachment of an artificial heart valve holder to an artificial heart valve. This holder Is used for positioning a prosthetic heart valve during transplant surgery. In one aspect, this transfer Implant surgery is an invasive procedure, such as when performed with a small trocar or similar device. It is the least aggressive surgery. Holder and valve are connected via trocar During insertion, it is carried on the distal end of a handle extending perpendicular to the axis of the annulus. This departure For clarity, the holder and mounting mechanism will first be described generally.   This holder and mounting mechanism can be used with any suitable prosthetic heart valve. Yes, this suitable prosthetic heart valve includes Medtronic, Minneapolis, Minn. Medtronic, Inc., Shiley, Inc., Irving, CA .) And OmniScience Medical, Inc. of Grove Heights, Minnesota cience Medical Inc.). In general, shown here The artificial heart valve is in a schematic form, and the scope of the present invention is to provide a holder and an attachment mechanism. Is also intended to include the necessary deformations to accommodate different prosthetic heart valves .   FIG. 1 is an overhead view of the artificial heart valve 10. Prosthetic heart valve 10 is available in Minneapolis, Minnesota. A prosthetic heart valve of the type available from Medtronic of Squirrel and containing the main struts 12 It is to explain. The main strut 12 is connected to the prosthetic heart valve body 14. Heart valve book Body 14 forms a substantially circular annulus for blood flow therethrough. A suture cuff 16 is attached to the valve body 14 to secure the valve 10 to the patient's heart. Used for attaching. The obturator 18 is located within the annulus formed by the orifice body 14. And is guided by a main strut 12. The occluder 18 is in the open position shown in FIG. Between the closed position and the closed position. The main strut 12 is guided by an obturator 18 Which are formed of elongated members, some of which extend parallel to the axis of the valve 10. Is running. Other examples of prosthetic heart valves for placing struts are described, for example, in US Pat. No. 787, 3,781,969, and 4,532,659. .   The strut is a useful attachment point for attaching the heart valve holder to the artificial heart. And have been found. The supporting material is a heart valve holder artificial heart valve with a low profile design It is particularly useful in mounting to Such a low profile (low profile) The design is international publication WO Well-suited for use with minimally invasive techniques described in US Pat. You.   FIG. 2A illustrates a valve holder in accordance with one aspect of the present invention engaged with the prosthetic heart valve 10 of FIG. It is a sectional side view of da. The prosthetic valve 10 has a second valve support which cannot be seen in FIG. Material 22. FIG. 2B is a top plan view of the holder 20 through which it projects. The main strut 12 is shown.   Holder 20 is a holder suitable for fitting within rim 26 of prosthetic heart valve body 14 It has a main body 24. The holder body 24 is opened with a support member through which the main support member 12 is received. It has a mouth 28. Whether the obturator engaging surfaces 30 and 32 are prosthetic heart valve holder body 24 And engages the closure 18 substantially as shown in FIG. 2A. Surface 30 and 32 maintains the obturator 18 in the closed position. The locking bar 34 is the main support The main member 12 is fitted between the member 12 and the holder main body 24. Rock bar 3 4 is connected to the holder body 24 via a spring-loaded lock bar cantilever 36 I do.   The holder 20 has a contact surface between the holder body 24 and the edge 26 of the prosthetic heart valve body 14 ( interface) with the prosthetic heart valve 10 and contact between the lock bar 34 and the main strut 12 Fixed by face. The coupling flange 40 is located above the surface 23 on the holder body 24. And receive suture 42 therethrough. The suture 42 is inserted into the suture hole 44 and Extending through the lock bar 34 to bring the lock bar 34 into the locked position shown in FIG. 2B. Fix it.   During the implantation procedure, the surgeon is substantially parallel to the plane of the valve 10 and The valve 10 is operated with an elongated handle 48 extending in a substantially vertical direction. Surgeon The valve 10 is sutured to the heart tissue annulus using a suture cuff 16. Valve to the heart tissue annulus Following attachment of the suture 10, the suture 42 is cut, thereby causing the cantilever 36 to lock. The holder 20 is removed by releasing the engagement between the hook bar 34 and the main suture 12. Remove. Following the release of the engagement between the lock bar 34 and the main suture 12, the holder 20 is removed. Lifted from the valve 10 so that the obturator 18 is free to pivot about the main suture 12 Be able to turn. During the implantation procedure, the occluder 18 is held in a substantially occluded position. And is protected by the prosthetic heart valve body 14 and the holder 20.   FIG. 3A shows a heart valve holder 6 according to another aspect engaged with a prosthetic heart valve 10. 0 is a side sectional view. The holder 60 has a holder body 62, and the holder body 62 It has a suture hole 64 therethrough. Suture opening 64 receives main suture 12 Suitable for The holder body 62 has an occluder contact surface 66 suitable for engagement with the occluder 18. Having. The contact surface 66 maintains the obturator 18 in the closed position shown in FIG. 3A. . Suture opening 70 extends through holder body 62 and receives suture 72. . Suture 72 extends through cuff 16 so that suture 72 and opening 64 The holder 60 is attached to the prosthetic heart valve 10 by the main suture 12 extending therethrough. Be killed.   Subsequent to the implantation procedure, the suture 72 is cut so that the holder 60 Remove. Thereafter, the holder 60 is lifted from the main suture 12 and thereby closed. The container 18 is released. Typically, the handle (not shown in FIGS. 3A and 3B) 0 extends in a direction (ie, laterally) parallel to the plane of the valve orifice body 14, Used to operate the valve 10 during a transplant operation.   FIG. 4A shows a heart valve holder 8 according to another aspect engaged with a prosthetic heart valve 10. 0 is a sectional view. FIG. 4B shows the top of the holder 80 engaged with the prosthetic heart valve 10. It is a partial plan view. The holder 80 includes main bodies 82A and 82B and a lock 84A. And 84B. The main bodies 82A and 82B are connected by a hinge 86, and 84A and 84B are separated along the dashed line indicated at 88. Holder 80 4B, the anchors 84A and 84B are below the main suture 12 Abuts along line 88. Holder 80 is held by fixing portions 84A and 84B. Formed surface 90 which engages occluder 18. The surface 92 is the main body 82 A and 82B, which are adapted for engagement with the occluder 18.   In the engaged position shown in FIG. 4B, the occluder 18 is in the closed position shown in FIG. 4A. Is held in place. Sutures 84A and 84B extend through suture holes 96 Held together by thread 94. Following implantation of the valve 10, the suture 94 is cut. By disconnecting, the body portions 82A and 82B can move together, Pivoting about 86, which causes portions 84A and 84B to move away The holder 80 is removed so that the valve 10 is released from the holder 80. Hinge 86 May include any suitable material including a flexible material integrally formed with the body portions 82A and 82B. Hinge mechanism. Typically, an extension not shown in FIGS. 4A and 4B In the direction parallel to the surface of the valve orifice body 14 (ie, sideways), the valve holder 80 , Which allows manipulation of the valve 10 during the implantation procedure.   A variation of the embodiment of holder 80 shown in FIGS. 4A and 4B includes a removal hinge 86. As such, the holder 80 includes one half 82A and 84A and the other half 82A and 84A. Is separable into two halves, including portions 82B and 84B. In this aspect A second attachment mechanism, such as a suture, extends between portions 82A and 82B. I have.   The present invention is inclusive of all modifications or aspects apparent to those skilled in the art. It should be understood that it spreads in. The concept described here is Applicable to any suitable valve configuration for both mitral valve implantation procedures. For example In the description given here, the configurations of the mitral valve and the aorta are interchanged. (See FIGS. 3A and 3B with FIGS. 1, 2A, 2B, 4A and 4B. Sea urchin). Further, the suture utilizes engagement mechanisms and techniques that are within the scope of the present invention. As far as it is possible, it can be placed in any other suitable position of the prosthetic heart valve . Including a retention mechanism in any embodiment to secure the occluder during the transplant operation Can be. Extended handle described here to operate prosthetic heart valve during transplant operation Holder Can be attached to   Although the present invention has been described with reference to preferred embodiments, those skilled in the art will Changes may be made in form and detail without departing from the spirit and scope of the invention. Would admit.

Claims (1)

【特許請求の範囲】 １．人工心臓弁本体、可動閉塞器及び取り外し可能な閉塞器を坦持する縫合糸を 具備する人工心臓弁を、移植手術の間保持する装置であって、 人工心臓との衝接に適合するホルダ本体、 ホルダ本体が人工心臓弁と係合している場合に可動閉塞器に適合し、可動閉 塞器を実質的に閉塞位置に維持するホルダ本体上表面、及び 前記縫合糸に係合するように適合され、それによりホルダ本体を縫合糸と人 工心臓弁との間に固定する取り付け機構を具備した装置。 ２． ホルダ本体が人工心臓弁の縁と衝接するための縁（リップ）を具備した請 求項１記載の装置。 ３． 取り付け機構がホルダ本体と縫合糸の一部との間に延びるロックバーを具 備した請求項１記載の装置。 ４． ホルダ本体がロックバーに隣接する縫合糸孔を具備し、この縫合糸孔はそ れを通してロックバーの上部に延びる縫合糸を受け入れるためのものであり、そ れによってロックバーがホルダ本体と縫合糸の一部との間の位置に維持される請 求項３記載の装置。 ５． ロックバーをホルダ本体に連結させる、ばね負荷されたロックバーカンチ レバを具備した請求項３記載の装置。 ６． ホルダ本体がそれを貫通する縫合糸孔を具備し、かつ人工心 臓弁が縫合カフを具備する請求項１記載の装置であって、該縫合糸孔はそれを通 る縫合糸を受け入れてホルダ本体を人工心臓弁に固定するのに適合したものであ る装置。 ７． 取り付け機構がホルダ本体に形成される縫合糸開口部を具備し、該縫合糸 開口部はこれを通して縫合糸を受け入れるためのものである請求項１記載の装置 。 ８． ホルダ本体が縫合糸開口部に隣接するヒンジで旋回可能に連結された第１ 本体部及び第２本体部を具備し、該第１及び第２本体部は、縫合糸が解放されて いる開放位置と、縫合糸が該第１及び第２本体部の間の縫合糸開口部に固定され る閉塞位置との間で旋回可能である請求項７記載の装置。 ９． 前記第１及び第２本体部に解除可能に連結されて前記第１及び第２本体部 を閉塞位置に維持する縫合糸を具備した請求項８記載の装置。[Claims] 1. Sutures carrying the prosthetic heart valve body, the movable occluder and the removable occluder An apparatus for retaining a prosthetic heart valve comprising during an implantation procedure,     Holder body suitable for contact with artificial heart,     Compatible with the movable occluder when the holder body is engaged with the artificial heart valve, An upper surface of the holder body for maintaining the embolic device in a substantially closed position; and     Adapted to engage the suture, thereby holding the holder body with the suture. An apparatus having an attachment mechanism for fixing between an engineered heart valve. 2. The holder body has an edge (lip) for abutting against the edge of the artificial heart valve. The device of claim 1. 3. An attachment mechanism includes a lock bar extending between the holder body and a portion of the suture. The apparatus of claim 1 provided. 4. The holder body has a suture hole adjacent to the lock bar, and the suture hole is To receive the suture that extends through it to the top of the lock bar. This ensures that the lock bar is maintained in a position between the holder body and a portion of the suture. The device of claim 3. 5. A spring-loaded lock bar cantilever that connects the lock bar to the holder body 4. The device according to claim 3, comprising a lever. 6. A holder body having a suture hole therethrough; The device of claim 1, wherein the splanchnic valve comprises a suture cuff, wherein the suture hole passes therethrough. Adapted to receive a suture and secure the holder body to the prosthetic heart valve. Device. 7. An attachment mechanism having a suture opening formed in the holder body; The device of claim 1, wherein the opening is for receiving a suture therethrough. . 8. A first body pivotally connected to the holder body by a hinge adjacent the suture opening; A main body portion and a second main body portion, wherein the first and second main body portions have a suture released. An open position and a suture secured to the suture opening between the first and second body portions. The device of claim 7, wherein the device is pivotable between a closed position and a closed position. 9. The first and second body portions are releasably connected to the first and second body portions. 9. The device of claim 8, comprising a suture to maintain the suture in the closed position.
JP9512034A 1995-09-14 1996-09-09 Device for mounting a heart valve holder on an artificial heart valve Pending JPH11513273A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/528,361 US5695503A (en) 1995-09-14 1995-09-14 Apparatus for attachment of heart valve holder to heart valve prosthesis
US08/528,361 1995-09-14
PCT/US1996/014464 WO1997009933A1 (en) 1995-09-14 1996-09-09 Apparatus for attachment of heart valve holder to heart valve prosthesis

Publications (1)

Publication Number Publication Date
JPH11513273A true JPH11513273A (en) 1999-11-16

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US (2) US5695503A (en)
EP (1) EP0955895B1 (en)
JP (1) JPH11513273A (en)
DE (1) DE69635138T2 (en)
WO (1) WO1997009933A1 (en)

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US5695503A (en) 1997-12-09
DE69635138T2 (en) 2006-01-26
WO1997009933A1 (en) 1997-03-20
EP0955895B1 (en) 2005-08-31
EP0955895A1 (en) 1999-11-17
EP0955895A4 (en) 2000-04-12
US5904695A (en) 1999-05-18
DE69635138D1 (en) 2005-10-06

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